PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
详细描述
OBJECTIVES:
- Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma.
- Assess the biological effects of 3F8/GM-CSF in these patients.
OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Neuroblastoma diagnosed by INSS criteria, i.e., either:
- •Histologic proof of disease OR
- •Tumor clumps in bone marrow plus elevated catecholamine levels
- •Relapsed disease with poor long-term prognosis as indicated by at least one of the following:
- •N-myc amplification in tumor cells
- •Diploid chromosomal content in tumor cells
- •Distant skeletal metastases
- •Unresectable primary tumor crossing the midline
- •Bone marrow with greater than 10% tumor cells
- •Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required
- •No rapidly progressive disease
- •Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Greater than 8 weeks
- •Hematologic:
- •Not specified
- •No grade 3/4 toxicity
- •LDH no greater than 1.5 times upper limit of normal
- •Creatinine clearance at least 60 mL/min
- •No grade 3/4 toxicity
- •Cardiovascular:
- •No grade 3/4 toxicity
- •No grade 3/4 toxicity
- •No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit
- •No active life threatening infections
- •No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL
- •No allergy to mouse proteins
- •No pain requiring opiates
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供